BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7014378 · Received November 9, 2017

    Report

    Report Number
    3007700286-2017-00122
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 8, 2017
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K080398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE GUIDE, IFU, CERTIFICATES OF ANALYSIS AND FMEA THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. HEMATOMA IS A KNOWN, INHERENT RISK OF SURGERY. PART NUMBERS: 1ST (SUPERIOR): LOT NUMBERS: IFUSE IMPLANT, P/N 7050M-90, LOT# 2591251, MANUFACTURING DATES AND EXPIRATION DATES AND UDI NUMBERS: MFD. 06/13/2017, EXPIRES 2022-06, (B)(4); 2ND (SECOND): IFUSE IMPLANT, P/N 7040M-90, LOT# 2591231, MFD. 06/02/2017, EXPIRES 2022-06, (B)(4); 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040M-90, LOT# 2591231, MFD. 06/02/2017, EXPIRES 2022-06, (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2017, THE PATIENT UNDERWENT RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER PRESENTED TO THE HOSPITAL EMERGENCY ROOM WITH PAIN FROM A HEMATOMA IN THE LATERAL ASPECT OF THE THIGH. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY TREATMENT FOR THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794573 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O